SUCCESS IN MEDICAL DEVICES MAY BE EASIER THAN YOU THINK – PART 3: THE COMPANY PERSPECTIVE

February 21, 2017 Posted by: Joe Martinez, RPh, PDE, PPC

This is the third and last part of a 3-part series on strategic considerations for patient engagement, market access and promotion for medical devices and procedures. In this blog, we’ll discuss the important factors from the Company’s perspective. We’ll look to discuss what the mission critical factors are for device success, after you’ve completed all the basic check boxes. As a disclaimer, the following thoughts and opinions are mine and any similarity to any real or imagined experiences are purely coincidental.

For those who know me, I have been an insulin-using diabetic for over 20 years. I have been wearing an insulin pump and continuous glucose sensor for the past 8 years or so. The pump gets changed every 72 hours and the sensor every 7 days. That means that twice a week something is being changed if everything is working right. In addition, my blood glucose is checked with ‘finger sticks’ between 4 and 8 times per day with a glucose meter. With that in mind, I write this with the experiences of the patient, former Medicaid director and health plan payer and former head of medical and clinical for a biotech device company. Please read on…

The end first – Here is the end-game: 1) Define success for your device and company in terms of the patient, 2) Identify and clarify your business model, expectations and value messaging in terms of #1, and 3) Build awareness, education and advocacy early on in terms of quality, outcomes and ease-of-use.

The good news is there’s a simple formula that I follow that distills this knowledge and serves as a reminder of the important factors: (D*M/Pr2)*Pa=S, where D=Device, M=Business Model, Pr=Process, Pa=Patient and S=Success. Here’s an easy way to determine what these factors are and their relative importance.

First – 1) Define success for your device and company in terms of the patient. Many times we get caught up in the numbers, projections, modeling, scaling, value messaging and a host of assorted items that create a ‘metrics’ for the product. We should remember that the real focus should be the patient and their ‘experience’ with the device.

D – The device and its importance to understand all that it implies:
• Whether the device is for an acute or chronic condition will determine the motivation of the patient to use it
• Will the device and medication provide a cure or only symptomatic relief. In other words, is this a ‘life sentence’ for the patient or just a momentary inconvenience?
• When the patient uses it, will the world know or just their friends and family because all we (the patient) want to be and look like is ‘normal’.
• Devices usually come packed in boxes, not bottles. These boxes take up considerably more space in the patient’s home, the local or specialty pharmacy and the physician’s office on the sample shelf. Double this down for ease of convenience for items that require refrigeration or the freezer. Also, does the medication come within the device or is it separate?

Pa – The patient and how the patient thinks and feels about their situation:
• Most importantly, how does the patient measure success? For the patient its not about the health plan, quality report or lab values. It’s more about things like not going to the bathroom as frequently during the day, buying a dress one size smaller or tightening your belt one notch tighter; in essence, identify the factors that the patient sees on a daily/weekly/monthly basis that they will feel good about.

Second – 2) Identify and clarify your business model, expectations and value messaging in term of #1

M – The business model and the choices made by the product management team. The business model overlaps #1, #2 and #3 –
• How easy it is for the patient to actually do what is asked of them?
• What is the training process, where is the instruction given and who pays for it?
• How easy is it for the patient and/or their caregiver to get answers for those early questions?

Pr – Processes that together make up the business model:
• Too many processes, paths, data flows and checkpoints, and the ‘system’ becomes ungainly like that of an elephant on roller skates. It may be a good show but few will ultimately be able to do it.
• Alternatively, too few processes and you leave much to chance, data flows and checkpoints, and the odds of a great experience are like picking the winner of the Powerball lottery, a nice prize but we have a better chance of seeing that mythical unicorn.

It’s mostly all about the patient experience. You must identify and manage expectations that go to ensuring a great experience, not just good and definitely better than mediocre. It is these expectations that enable the patient to be ‘comfortable’ attaching, using, injecting and feeling successful with the device and therapy. The comfort of the patient enables the physician to continue writing the prescription and the plan to keep paying for it.

Third – 3) Build awareness, education and advocacy early on in terms of quality, outcomes and ease-of-use. Tell your story and do no stop!

• Craft your story with your value messaging points that can be told in 30-seconds, 3-minutes and 18-minutes. The 30-second message creates awareness, 3-minutes buys you more time and 18-minutes is your discussion.
• Begin communicating 6 to 12 months before clearance or approval with your medical and/or HEOR teams who can speak with clinicians, payers and investigators under FDA, FDAMA 114 and AdvaMed Code of Ethics guidelines. This also includes scientific and medical publications and generating a steady and consistent supply of compliant information.
• Create compelling reasons for people to take action by knowing and understanding their agenda items and needs. This means to do the right things and in the right order to ensure a great patient experience, prescriber support and payer access. (i.e. “The dog bit Johnny” means something very different from “Johnny bit the dog” – the same words in a different order will have different meanings and results.)

In summary – Features and benefits are important but only as much as they describe and deliver a great patient experience. Once a day is better than twice a day; an oral tablet is better than an injectable; a tubeless device is considered more convenient than a device with tubing; a small box is more convenient to store than a large box; POS (point of sale) supplies is more convenient than direct-to-patient supplies (be careful on this one because it is changing); in-office training at the point of decision is more convenient than scheduling another appointment with another person – in short, there are many factors to consider and when you focus on the patient and their ‘real’ needs your device will become a part of their life and your success!